ASNIS 325240Recalls & reported problems
Stryker GmbH · ASNIS III Screw StSt · Class 2 · Implant
All models of ASNIS (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327142921), received between Jan 11, 2021 and Jan 11, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2021Fracture; Fracture
"AS REPORTED: "DR. WAS OPERATING ON A FEMALE WITH A TRIMOLECULAR ANKLE FRACTURE. DR. FIXED THE MEDIAL MALLEOLUS USING 2 THREADED GUIDEWIRES FROM THE ASNIS 3 STAINLESS STEEL TRAY AND UTILIZED 2 PARTIALLY THREADED STAINLESS STEEL SCREWS TO COMPRESS THE FRACTURE AFTER USING THE 2.7 CANNULATED DRILL BIT. DR. WANTED TO COMPRESS THE SYNDESMOSIS JOINT UTILIZING 2 FULLY THREADED STAINLESS STEEL SCREWS FROM THE ASNIS 3 STAINLESS STEEL TRAY. DR. PLACED 2 THREADED GUIDEWIRES THROUGH THE NEAR AND FAR CORTEX OF THE FIBULA AND IN THE NEAR CORTEX OF THE TIBIA FOR A TOTAL OF 3 CORTICES. DR. MEASURED FOR THE SCREW WHICH WAS A 40 AND DRILLED WITH THE CANNULATED 2.7 DRILL BIT. AS HE ENTERED NEAR TIBIAL CORTEX, HE FELT A SLIGHT CLICK AND WE GOT AN X-RAY OF AN UNFAMILIAR OBJECT. AS WE FURTHER INVESTIGATED WITH FLUOROSCOPIC X-RAY WE PREDICTED THAT THE SCREW WAS TEARING ITSELF APART. WE THEN PROCEEDED WITH THE DISTAL FULLY THREADED SCREW AND A PART OF THE SELF TAPPING TIP OF THE SCREW FELL OFF DURING INSERTION. WE FOUND THIS OUT USING X-RAY. WE THEN REMOVED THE DISTAL SIZE 48 FULLY THREADED STAINLESS STEEL SCREW AND REPLACED IT WITH A NEW ONE THAT WAS SUCCESSFUL. DR. REMOVED THE 40MM FULLY THREADED SCREW
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11152659 ↗
Other Screw, fixation, bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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